COMMISSIONING AND QUALIFICATION OF BIOPHARMACEUTICAL CLEANROOMS
This application note provides a guideline of the steps and documentation needed to properly commission and qualify a biopharmaceutical cleanroom.
Risk-Based Development Supporting Process Qualification for Spray-Dried Dispersion
November 13th 2024Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products. Watch this video to learn more about:
Key Drivers to Overcome Obstacles in mAbs Formulation and Fill-Finish
November 8th 2024Despite selecting the right, compendial excipients for a balanced formulation, you may encounter obstacles that delay market deadlines. Learn how to streamline the formulation and fill-finish process with the right raw material selection, secure and efficient fluid pathway design, comprehensive regulatory support, and supply chain transparency.
Integrated buffer prep solutions
November 8th 2024Biopharma companies often lack the capacity and infrastructure to handle large buffer volumes needed for mAb production. Avantor offers four key strategies to improve operational efficiencies and reduce facility footprint, such as pre-weighed, GMP-compliant raw materials or ready-to-use hydrated solutions. Learn more about these customizable solutions.
Adopting novel technologies to improve monoclonal antibody processes
November 8th 2024The growing complexity of therapeutic monoclonal antibodies (mAbs), especially bispecific antibodies, presents significant manufacturing challenges such as instability, low yields and aggregation. This article explores innovative solutions, including detergent-based viral inactivation as an alternative to low pH treatment, high- performance chromatography ligands and advanced formulation excipients.
